NCT02779101

Study on Pembrolizumab for Recurrent Primary Central Nervous System Lymphoma (PCNSL)

Open-label Single Arm Phase II Study on Pembrolizumab for Recurrent Primary Central Nervous System Lymphoma (PCNSL)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: Prof. Dr. Matthias Preusser · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In summary, there is a high medical need for patients suffering from recurrent/progressive PCNSL. Targeting the PD-1 pathway may represent a very promising novel approach for the treatment of these patients.

Detailed description

The objective of this study are: PRIMARY OBJECTIVES * To evaluate the Overall Response Rate (CR/PR) in patients treated with pembrolizumab for relapsed PCNSL after MTX-based first-line therapy * To evaluate the safety of pembrolizumab in subjects diagnosed with recurrent PCNSL SECONDARY OBJECTIVES * To describe Best Overall Response categories (CR, PR, SD, PD) in patients treated with pembrolizumab for relapsed PCNSL after MTX-based first-line therapy * To describe individual duration of response over time * To assess progression-free survival in this patient population * To assess overall survival in this patient population EXPLORATORY OBJECTIVES * To assess PD-L1 as a predictive marker for response to pembrolizumab

Conditions

• Primary Central Nervous System Lymphoma

Interventions

Type	Name	Description
DRUG	pembrolizumab	Pembrolizumab 200 mg every 3 weeks

Timeline

• Start date: 2016-06-01
• Primary completion: 2018-06-01
• Completion: 2019-06-01
• First posted: 2016-05-20
• Last updated: 2016-06-22

Locations

1 site across 1 country: Austria